Phase 4 N=87 Randomized Triple-blind Treatment

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Dyspepsia · Emergency · Pain

Bottom Line

View on ClinicalTrials.gov: NCT01281501 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment — 17; 19 millimeter — p=0.6

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Normal saline (Drug); Pantoprazole (Drug); Oral antacid (Drug); Hyoscine butylbromide (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Chulalongkorn University
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment	17; 19	0.6
SECONDARY Number of Participants in the Predefined "Responders"	36; 32	—
SECONDARY Number of Participants in the Predefined "Non-responders"	8; 11	—
SECONDARY Number of Participants With Adverse Effect	—	—
SECONDARY Number of Participants That Have Overall Satisfaction on the Treatment	34; 34	—

Summary

The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).

Eligibility Criteria

Inclusion Criteria

clinical diagnosis of acid-related dyspepsia
age 15 to 50 years

Exclusion Criteria

pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less than 5.0
known cases of malignancies or terminal illnesses
known cases of major medical problems
allergic to studied drugs
contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic enlargement, porphyria)
received acid antisecretory agents (proton pump inhibitors or histamine-2 receptor antagonists), antispasmodic agents, alcoholic consumption, nonsteroidal anti-inflammatory drugs, aspirin and steroids within 5 days or oral antacids within 4 hours prior to the visit
receiving clopidogrel, statins, iron therapies, warfarins, antiretroviral agents, which may have serious drug interaction with the proton pump inhibitors
receiving drugs that have strong anticholinergic activities (e.g. acetylcholinesterase inhibitors for Parkinson's or Alzheimer diseases, antihistamines, antispasmodic agents, antipsychotics, skeletal muscle relaxants, tricyclic antidepressants) or decongestants, which may have serious drug interaction with hyoscine butylbromide
suspected other alternative diagnoses (e.g. gut obstruction, biliary colic, pancreatitis, hepatitis or localized hepatobiliary infections, etc.)
pregnancy or breast-feeding participants
did not comprehend the Visual Analog Scale (VAS) evaluation

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Data sourced from ClinicalTrials.gov (NCT01281501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.